ID

40124

Beschrijving

Renal Denervation for Treatment of Resistant Hypertension in Patients With Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01747382

Link

https://clinicaltrials.gov/show/NCT01747382

Trefwoorden

Versies (1)
  1. 13-03-20 13-03-20 -
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See clinicaltrials.gov

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13 maart 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT01747382

Engels

Eligibility Hypertension NCT01747382

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. individual has a systolic blood pressure ≥ 160 mmhg (≥ 150 mmhg for type 2 diabetics).
Beschrijving

Systolic Pressure | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0011860
2. individual is adhering to a stable drug regimen including 3 or more anti-hypertensive medications, of which one is a diuretic, (with no changes for a minimum of 2 weeks prior to enrollment) and is expected to be maintained for at least 6 months.
Beschrijving

Pharmacotherapy Stable | Antihypertensive Agents Quantity unchanged | Diuretics

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0442739
UMLS CUI [3]
C0012798
3. individual with stage 3 chronic kidney disease, defined as having an egfr of 30 - 60 ml/min/1.73m2, using the mdrd calculation.
Beschrijving

Chronic Kidney Disease Stage | GFR estimation by MDRD

Datatype

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
UMLS CUI [2]
C2170215
4. individual is ≥ 21 and ≤ 65 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study
Beschrijving

Protocol Compliance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. individual has renal artery anatomy that is ineligible for treatment including:
Beschrijving

Renal artery Anatomy Ineligible Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1512714
UMLS CUI [1,4]
C0087111
1. main renal arteries < 4 mm in diameter or < 20 mm in length.
Beschrijving

Renal artery Main Diameter | Renal artery Main Length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C1301886
UMLS CUI [2,1]
C0035065
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1444754
2. hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation.
Beschrijving

Renal artery Abnormality Hemodynamics | Renal artery Abnormality Anatomy | Renal Artery Stenosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0019010
UMLS CUI [2,1]
C0035065
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0700276
UMLS CUI [3]
C0035067
3. a history of prior renal artery intervention including balloon angioplasty or stenting.
Beschrijving

Renal artery Intervention | Angioplasty, Balloon | Stenting

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0184661
UMLS CUI [2]
C0002996
UMLS CUI [3]
C2348535
4. multiple main renal arteries in either kidney.
Beschrijving

Renal artery Main Multiple | Kidney Either

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C0439064
UMLS CUI [2,1]
C0022646
UMLS CUI [2,2]
C3844638
2. individual has an estimated glomerular filtration rate (egfr) of < 30ml/min/1.73m2, using the mdrd calculation.
Beschrijving

GFR estimation by MDRD

Datatype

boolean

Alias
UMLS CUI [1]
C2170215
3. individual has type 1 diabetes mellitus.
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
4. individual has experienced a myocardial infarction, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
Beschrijving

Myocardial Infarction | Cerebrovascular accident | Atherosclerosis Widespread | Intravascular thrombosis | Plaque Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0004153
UMLS CUI [3,2]
C0205391
UMLS CUI [4]
C0442860
UMLS CUI [5,1]
C4316797
UMLS CUI [5,2]
C0443343
5. individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
Beschrijving

Patient scheduled for surgery | Intervention Cardiovascular Scheduled | Operative Surgical Procedure Planned | Intervention Cardiovascular Planned

Datatype

boolean

Alias
UMLS CUI [1]
C3242215
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C3887460
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C3887460
UMLS CUI [4,3]
C1301732
6. individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
Beschrijving

Heart valve disease Hemodynamics Significance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
7. individual has an implantable cardioverter defibrillator (icd) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (mri).
Beschrijving

Implantable defibrillator | Pacemaker | Metallic implant Inconsistent MRI

Datatype

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C0810633
UMLS CUI [3,1]
C3693688
UMLS CUI [3,2]
C0442809
UMLS CUI [3,3]
C0024485
8. individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
Beschrijving

Medical condition Interferes with Patient safety | Medical condition Interferes with Evaluation | Peripheral Vascular Disease | Aortic Aneurysm, Abdominal | Blood Coagulation Disorders | Thrombocytopenia | Hemophilia | Anemia | Cardiac Arrhythmia | Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [3]
C0085096
UMLS CUI [4]
C0162871
UMLS CUI [5]
C0005779
UMLS CUI [6]
C0040034
UMLS CUI [7]
C0684275
UMLS CUI [8]
C0002871
UMLS CUI [9]
C0003811
UMLS CUI [10]
C0004238
9. individual is pregnant, nursing or planning to be pregnant. [female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hcg) pregnancy test prior to treatment.]
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine hCG pregnancy test Negative

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430060
UMLS CUI [4,3]
C1513916
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C2188702
UMLS CUI [5,3]
C1513916
10. individual is currently enrolled in another investigational drug or device trial.
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Hypertension NCT01747382

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Systolic Pressure | Diabetes Mellitus, Non-Insulin-Dependent
Item
1. individual has a systolic blood pressure ≥ 160 mmhg (≥ 150 mmhg for type 2 diabetics).
boolean
C0871470 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Pharmacotherapy Stable | Antihypertensive Agents Quantity unchanged | Diuretics
Item
2. individual is adhering to a stable drug regimen including 3 or more anti-hypertensive medications, of which one is a diuretic, (with no changes for a minimum of 2 weeks prior to enrollment) and is expected to be maintained for at least 6 months.
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
C0012798 (UMLS CUI [3])
Chronic Kidney Disease Stage | GFR estimation by MDRD
Item
3. individual with stage 3 chronic kidney disease, defined as having an egfr of 30 - 60 ml/min/1.73m2, using the mdrd calculation.
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Age
Item
4. individual is ≥ 21 and ≤ 65 years of age.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance | Informed Consent
Item
5. individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Renal artery Anatomy Ineligible Treatment
Item
1. individual has renal artery anatomy that is ineligible for treatment including:
boolean
C0035065 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Renal artery Main Diameter | Renal artery Main Length
Item
1. main renal arteries < 4 mm in diameter or < 20 mm in length.
boolean
C0035065 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0035065 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1444754 (UMLS CUI [2,3])
Renal artery Abnormality Hemodynamics | Renal artery Abnormality Anatomy | Renal Artery Stenosis
Item
2. hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation.
boolean
C0035065 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0019010 (UMLS CUI [1,3])
C0035065 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0700276 (UMLS CUI [2,3])
C0035067 (UMLS CUI [3])
Renal artery Intervention | Angioplasty, Balloon | Stenting
Item
3. a history of prior renal artery intervention including balloon angioplasty or stenting.
boolean
C0035065 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0002996 (UMLS CUI [2])
C2348535 (UMLS CUI [3])
Renal artery Main Multiple | Kidney Either
Item
4. multiple main renal arteries in either kidney.
boolean
C0035065 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0022646 (UMLS CUI [2,1])
C3844638 (UMLS CUI [2,2])
GFR estimation by MDRD
Item
2. individual has an estimated glomerular filtration rate (egfr) of < 30ml/min/1.73m2, using the mdrd calculation.
boolean
C2170215 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
3. individual has type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Atherosclerosis Widespread | Intravascular thrombosis | Plaque Unstable
Item
4. individual has experienced a myocardial infarction, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0004153 (UMLS CUI [3,1])
C0205391 (UMLS CUI [3,2])
C0442860 (UMLS CUI [4])
C4316797 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
Patient scheduled for surgery | Intervention Cardiovascular Scheduled | Operative Surgical Procedure Planned | Intervention Cardiovascular Planned
Item
5. individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
boolean
C3242215 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C3887460 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0184661 (UMLS CUI [4,1])
C3887460 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Heart valve disease Hemodynamics Significance
Item
6. individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Implantable defibrillator | Pacemaker | Metallic implant Inconsistent MRI
Item
7. individual has an implantable cardioverter defibrillator (icd) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (mri).
boolean
C0162589 (UMLS CUI [1])
C0810633 (UMLS CUI [2])
C3693688 (UMLS CUI [3,1])
C0442809 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
Medical condition Interferes with Patient safety | Medical condition Interferes with Evaluation | Peripheral Vascular Disease | Aortic Aneurysm, Abdominal | Blood Coagulation Disorders | Thrombocytopenia | Hemophilia | Anemia | Cardiac Arrhythmia | Atrial Fibrillation
Item
8. individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0085096 (UMLS CUI [3])
C0162871 (UMLS CUI [4])
C0005779 (UMLS CUI [5])
C0040034 (UMLS CUI [6])
C0684275 (UMLS CUI [7])
C0002871 (UMLS CUI [8])
C0003811 (UMLS CUI [9])
C0004238 (UMLS CUI [10])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine hCG pregnancy test Negative
Item
9. individual is pregnant, nursing or planning to be pregnant. [female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hcg) pregnancy test prior to treatment.]
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0430060 (UMLS CUI [4,2])
C1513916 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C2188702 (UMLS CUI [5,2])
C1513916 (UMLS CUI [5,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
10. individual is currently enrolled in another investigational drug or device trial.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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